التفاصيل البيبلوغرافية
| العنوان: |
Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer’s disease |
| المؤلفون: |
Farlow, Martin R., Andreasen, Niels, Riviere, Marie-Emmanuelle, Vostiar, Igor, Vitaliti, Alessandra, Sovago, Judit, Caputo, Angelika, Winblad, Bengt, Graf, Ana |
| المساهمون: |
Department of Neurology, IU School of Medicine |
| المصدر: |
PMC |
| بيانات النشر: |
BioMed Central |
| سنة النشر: |
2015 |
| المجموعة: |
Indiana University - Purdue University Indianapolis: IUPUI Scholar Works |
| مصطلحات موضوعية: |
Alzheimer's disease, CAD106, Aβ immunotherapy |
| الوصف: |
Introduction: CAD106 is designed to stimulate amyloid-β (Aβ)-specific antibody responses while avoiding T-cell autoimmune responses. The CAD106 first-in-human study demonstrated a favorable safety profile and promising antibody response. We investigated long-term safety, tolerability and antibody response after repeated CAD106 injections. Methods: Two phase IIa, 52-week, multicenter, randomized, double-blind, placebo-controlled core studies (2201; 2202) and two 66-week open-label extension studies (2201E; 2202E) were conducted in patients with mild Alzheimer’s disease (AD) aged 40 to 85 years. Patients were randomized to receive 150μg CAD106 or placebo given as three subcutaneous (2201) or subcutaneous/intramuscular (2202) injections, followed by four injections (150 μg CAD106; subcutaneous, 2201E1; intramuscular, 2202E1). Our primary objective was to evaluate the safety and tolerability of repeated injections, including monitoring cerebral magnetic resonance imaging scans, adverse events (AEs) and serious AEs (SAEs). Further objectives were to assess Aβ-specific antibody response in serum and Aβ-specific T-cell response (core only). Comparable Aβ-immunoglobulin G (IgG) exposure across studies supported pooled immune response assessments. Results: Fifty-eight patients were randomized (CAD106, n = 47; placebo, n = 11). Baseline demographics and characteristics were balanced. Forty-five patients entered extension studies. AEs occurred in 74.5% of CAD106-treated patients versus 63.6% of placebo-treated patients (core), and 82.2% experienced AEs during extension studies. Most AEs were mild to moderate in severity, were not study medication-related and did not require discontinuation. SAEs occurred in 19.1% of CAD106-treated patients and 36.4% of placebo-treated patients (core). One patient (CAD106-treated; 2201) reported a possibly study drug-related SAE of intracerebral hemorrhage. Four patients met criteria for amyloid-related imaging abnormalities (ARIA) corresponding to microhemorrhages: one was CAD106-treated ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| Relation: |
Alzheimer's Research & Therapy; Farlow, M. R., Andreasen, N., Riviere, M. E., Vostiar, I., Vitaliti, A., Sovago, J., . & Graf, A. (2015). Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer’s disease. Alzheimer's research & therapy, 7(1), 23.; https://hdl.handle.net/1805/6541 |
| الاتاحة: |
https://hdl.handle.net/1805/6541 |
| Rights: |
Attribution 3.0 United States ; http://creativecommons.org/licenses/by/3.0/us/ |
| رقم الانضمام: |
edsbas.EE867DA8 |
| قاعدة البيانات: |
BASE |